The Swiss Registry for Heart Diseases in Children Living in Switzerland. SPHC (SPHC)

The Swiss Registry for Heart Diseases in Children A Datacollection for Congenital and Acquired Heart Diseases in Children Living in Switzerland.

The Swiss Pediatric Heart Cohort aims to collect representative longitudinal data on all children diagnosed with a clinically relevant heart disease in Switzerland. The long-term goal is to optimize diagnosis and therapy, and to allow setting up national research projects.

Study Overview

• Status: Completed
• Conditions: Heart Disease Congenital

Detailed Description

In the entire spectrum of childhood diseases, heart disease occupy a special position regarding incidence; Congenital heart defects are among the most common organ abnormalities, moderate and severe forms of congenital heart diseases occur with a frequency of about 6 to 8 per 1000 live births. Rapid advances in diagnostic and therapeutic options in recent decades have led to a spectacular improvement in prognosis.

So far, data from heart diseases in children in Switzerland are not recorded centrally. A national registry collecting all relevant personal and medical data, as in other European countries, e.g. Finland, Sweden or Germany does not exist. The incidence and course of heart diseases in children in Switzerland are therefore unknown and can only be extrapolated indirectly from other countries. The SPHC project was therefore initiated by the Swiss pediatric cardiologists and is supported by its professional association, the Swiss Society for Pediatric Cardiology (Schweizerische Gesellschaft für pädiatrische Kardiologie; SGPK), as well as by its research association, the Association for Pediatric Heart Research Switzerland (Verein Kinderherzforschung Schweiz; VKHFS).

The aim of medical efforts in children with heart disease has shifted in recent years from a mere assurance of survival to an overall optimization of morbidity. These patients are expected to have a good perspective with normal growth, development, and quality of life well into adulthood. This goal can be achieved by researching the incidence and disease progression as well as the diagnostic and therapeutic measures in Switzerland. In this way, conclusions can be drawn, which lead to a modification of the therapeutic procedures and finally improve the prognosis of heart disease. The statistical significance of individual case descriptions or retrospective case series of individual centers, as practiced today, is insufficient for these purposes.

The aim of the SPHC is to optimize the diagnosis and therapy of all children with heart disease in Switzerland. In particular, the following goals are pursued:

• Describe incidence of heart diseases in childhood
• Enable research on the cause of the disease
• Record long-term history of mortality, morbidity and quality of life
• Describe therapeutic measures (medications, cardiac catheterization, cardiac surgery) regarding efficacy and safety
• Identify risk factors for a good / bad prognosis
• Promote prevention
• Collect basic data for the planning of care and for health economic analyses in the context of public health research projects
• Provide data for international collaborative studies
• A collaboration with Registry of adults with congenital heart defects (Grown Up Congenital Heart Disease, GUCH) is anticipated. This registry also uses SecuTrial® and is also located in the Clinical Trial Centre (CTC) of the University Zürich.

• Study Type: Observational
• Enrollment (Actual): 590

Contacts and Locations

• Study Contact: Name: Chantal Costan; Phone Number: +41796173734; Email: chantal.costan@kispi.uzh.ch
• Study Contact Backup: Name: Christan Balmer, PD; Phone Number: +41442667379; Email: christian.balmer@kispi.uzh.ch

Study Locations

• Switzerland
  • Zürich, Switzerland, 8032
    • University Childrens Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population from newborns to adolescents with newly diagnosed heart disease is recorded.

Description

Inclusion Criteria:

• Patients with heart diseases and
• age at diagnosis between 0 and 18 years and
• resident and / or treated in Switzerland and
• signed informed consent

Exclusion Criteria:

• No written consent. The number of people who refuse to participate will be recorded per center for drop out analysis.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPHC, a prospective quantitative datacollection of heart diseases in Swiss children during ten years.	This registry is a prospective data collection. It includes all patients who are newly diagnosed with a heart disease and who have consented to it. As the amount of data increases, the registry becomes more important and informative. The primarily outcome is to evaluate the quantity of congenital and acquired heart diseases in children living in Switzerland per Year compared to other countries.	Datacollection during 10 years, whereas an average incident is detected during one year

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Collaborators: Centre Hospitalier Universitaire Vaudois; Ostschweizer Kinderspital
• Investigators: Principal Investigator: Christian Balmer, PI

Publications and helpful links

Helpful Links

• Prevalence of congenital heart defects
• Incidence of congenital heart defects

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: pediatric; registry; congenital heart disease; heart disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: BASEC 2018-01229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Specific research projects: At the request of researchers, the SPHC is used for focused research projects. For example, a questionnaire study to patients and their parents to assess quality of life and health, or a survey to attending physicians for detailed treatment modalities. The additional data gained in these projects will be fed back into the database.

Networking: In the future there is a possibility that the data of the SPHC can be networked with further registries: e.g. Swiss Birth Registry (Swiss Federal Statistical Office), Swiss National Cohort, RADIZ: Registry for Rare Diseases, Swiss Ped Net and possible further registries. Also the cooperation with the registry for adults with congenital heart diseases (GUCH Registry) is essential and an inclusion of all SPHC patients reaching the age of 18 years in the GUCH registry is anticipated.

• IPD Sharing Time Frame: The first Data will be available 2020.
• IPD Sharing Access Criteria: all IPD that underlie results in a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No